Awareness Training on ISO 9001:2015

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C118 Awareness Training on ISO 90012015
PART 2
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Timeline to ISO 90012015 Revision Release and
Client Transition
2013 2014 2015 2015
2018
June 2013 CD(Committee Draft)
April 2014 DIS(Draft International Standard)
July 2015 FDIS(Final Draft International
Standard)
September 2015 (Published International Standard)
start of 3 years transition period to September
2018
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Seven principle of ISO/DIS 90012015
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ISO/DIS 9001 2015 Standard Overview

• 0 Introduction
• Scope
• Normative references
• Terms and definitions
• Context of organization
• Leadership
• Planning of QMS
• Support
• Operations
• Performance evaluation
• Improvement

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Main Changes

• Risk-based thinking throughout the standard
  supersedes a single clause on preventive action
• The term documented information replaces
  documents and records
• The term outsourcing is replaced by external
  provision
• Increased leadership requirements
• No requirement for a management representative

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Documented Information Required by ISO/DIS 9001
2015
List of Documented Information

1. Scope of the Quality management system(4.3 )
2. Quality policy (5.2)
3. Quality Objectives (6.2)
4. Evidence of fitness of monitoring and measuring
   devices or instrument calibration and maintenance
   records (7.1.4)
5. Competence records for employee experience,
   qualification, skill or certification etc (7.2d)
6. Necessary information for effectiveness of
   QMS-Objectives monitoring sheet (7.5.1b)
7. Change control and version control- change
   control sheet (7.5.3c)
8. External origin documents necessary for planning
   and execution of QMS (7.5.3)
9. Establish confidence on processes - Process
   monitoring sheet and monitoring records (Process
   execution ,monitoring against planning) (8.1c)
10. Contract review results against requirements and
    amendments (8.2.3)
11. Processes of the QMS and resources( Quality Plan)
    (8.3)
12. Results of evaluation of external providers -
    External providers selection and evaluation
    records (8.4.2)

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Clause 4.2 Understanding the needs expectations
of interested parties

• Interested parties
• The organization shall consider the following
  relevant interested parties
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• Direct customers
• End users
• Suppliers, distributors, retailers or others
  involved in the supply chain
• Regulators
• Any other relevant interested parties.

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Internal Context
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Areas to considered in risk and opportunity
identification

• Corporate Requirement
• Business Requirement
• Contractual Requirement
• Client/customer Requirement
• Process and product requirements
• Legislative Requirement
• Regulatory Requirement
• Statutory Requirements

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Thanks You
Form for information about ISO 90012015
certification consultancy, ISO 90012015
Awareness training as well as upgraded and
implements Quality Managements System visit _at_
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